FDA.reportPublic FDA data

510(k) K230765

Device
Precice Ankle Salvage System
Applicant
Nuvasive Specialized Orthopedics, Inc.
510(k) number
K230765
Product code
HSB
Decision
Substantially Equivalent (SESE)
Decision date
2023-08-29
Date received
2023-03-20
Regulation
888.3020
Classification name
Rod, Fixation, Intramedullary And Accessories
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Miriam Cervantes
Address
101 Enterprise, Suite 100 Alisa Viejo CA US 92656 92656

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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